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Wellue / Viatom
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BP2WModel BP2，BP2B，BP2V，BP2WRef BP2VRef Lepod ProModel M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12Ref PO6CRef ER1-LWModel ER1-LW，ER1-LBRef BP2AModel PO6B、PO6C
Identity
- Trade Name
- Wellue / Viatom EUDAMEDWellue EUDAMEDWellue/Viatom FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Blood Pressure Monitor EUDAMEDWireless Dynamic Multi-parameter Holter EUDAMEDPulse Oximeter EUDAMEDDynamic ECG Recorder EUDAMED
- Model / Reference
- BP2，BP2B，BP2V，BP2W EUDAMEDBP2W EUDAMEDBP2V EUDAMEDM5，M12，Lepod，Lepod Pro，LMT-5，LMT-12 EUDAMEDLepod Pro EUDAMEDPO6C EUDAMEDER1-LW，ER1-LB EUDAMEDER1-LW EUDAMEDBP2A EUDAMEDPO6B、PO6C EUDAMEDBP2A Blood Pressure Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934440102243 EUDAMED06934440102236 EUDAMED06934440102786 EUDAMED06934440102465 EUDAMED06934440101918 EUDAMED06934440101017 EUDAMEDFDA UDI
- Basic UDI-DI
- 69344401BP2XD EUDAMED69344401M12WA EUDAMEDB-06934440102465 EUDAMED69344401ER1-LWER EUDAMED69344401BP2AN7 EUDAMED69344401PO6BRJ EUDAMED
- Direct Marketing DI
- 06934440102243 EUDAMED06934440102236 EUDAMED06934440102786 EUDAMED06934440101918 EUDAMED06934440101017 EUDAMED06934440102465 EUDAMED
- 510(k) Number
- K193348 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020302,Z12050301 EUDAMEDZ12050402 MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.) EUDAMEDZ1203020408 PULSE OXIMETERS EUDAMEDZ12050403 ECG HOLTER RECORDERS EUDAMEDZ1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Wellue / Viatom by Shenzhen Viatom Technology Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69344401BP2XD | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69344401BP2XD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Viatom Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012182
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (8)
- EUDAMED f52df2ee-cc25-42b0-b298-3822853c92cd 61 fields · synced Jul 28, 2026
- EUDAMED 128edf9b-97bf-4311-9a34-69a0ee802b25 61 fields · synced May 17, 2026
- EUDAMED bad50ed2-0e6d-441f-8d4d-f47b8e11ec16 61 fields · synced May 17, 2026
- EUDAMED 06b4d44c-1856-4472-a75c-0ab4cab09d9f 61 fields · synced May 18, 2026
- EUDAMED 208cd8ea-1c85-4cd9-8b29-acde6bd13142 61 fields · synced May 18, 2026
- EUDAMED 191f4fa5-910b-4c2d-804b-a1d2fe3ee2a0 61 fields · synced May 19, 2026
- FDA UDI a47b4952-fd48-454b-87ce-5ba0cab3c28d 33 fields · synced May 30, 2026
- EUDAMED 64a65db3-18a7-4bf9-a0be-552e18e78d11 61 fields · synced Jul 10, 2026